(73 days)
The Lorenz Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
Lorenz Twist drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone.
This document, K062842, is a 510(k) summary for the Lorenz Twist Drills. A 510(k) submission is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device and does not, therefore, require a Premarket Approval (PMA).
This document does not contain information regarding detailed acceptance criteria or a study that proves the device meets specific performance criteria beyond substantial equivalence. 510(k) submissions typically focus on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, intended use, and performance data if relevant, rather than detailed clinical studies with specific performance benchmarks common for novel devices.
Therefore, many of the requested fields cannot be filled from the provided text because such information is not typically included in this type of FDA submission for devices like simple surgical drills.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in 510(k) summary | Not specified in 510(k) summary |
Explanation: The document does not describe specific numerical acceptance criteria (e.g., drill bit sharpness, durability over a certain number of uses, or specific force required for drilling) or quantitative performance data to meet such criteria. The 510(k) process for a device like a twist drill primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, implying that the performance is similar and acceptable based on the predicate's established safety and effectiveness. The materials (Stainless Steel) are mentioned, which is a key characteristic for comparison.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
Explanation: This 510(k) summary does not mention any specific test sets, clinical studies, or data provenance to evaluate the device's performance in a quantitative manner. The evaluation is centered on a comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment for a test set is described in this 510(k) summary. Surgical drills, particularly those intended for general bone drilling, typically do not require expert-established ground truth in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there is no described test set requiring one.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a manual/powered surgical drill, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As noted earlier, ground truth in the context of expert consensus or pathology is typically for diagnostic devices. For a surgical drill, the "ground truth" of its function would be its ability to drill holes in bone effectively and safely, traditionally assessed through engineering tests and comparison to established predicate devices, rather than a clinical ground truth established by experts in a diagnostic sense.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or ground truth establishment for such a set.
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Ya62842
Image /page/0/Picture/1 description: The image shows the logo for W. Lorenz Surgical, a Bionet Company. The logo is in black and white, with the words "W. Lorenz" in large, bold letters. Below that, the word "Surgical" is written in smaller letters. Underneath the word "Surgical" is the phrase "A Bionet Company".
510(k) Summary
1520 Tradeport Drive Jacksonville, FL 32218 904-741-4400 fax 904-741-4500
Device Name: Lorenz Twist Drills
JEC - 4 2006
Classification Name and Reference:
CFR 882.4300 Manual cranial drills, burrs, trephines, and their accessories CFR 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories CFR 872.4120 Bone cutting instrument and accessories CFR 878.4800 Manual surgical instrument for general use CFR 878.4820 Surgical instrument motors and accessories CFR 888.4540 Orthopedic manual surgical instrument
Device Classification: Class II, Class I
Device Description: Lorenz Twist drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone.
Intended Use: The Lorenz Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
Materials: Stainless Steel
Possible Adverse Effects:
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- Metal sensitivity reactions or allergic reaction to the implant material.
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- Pain, discomfort, or abnormal sensation due to the presence of the device.
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- Surgical trauma; permanent or temporary nerve damage, permanent or temporary damage to heart, lungs, and other organs, body structures or tissues.
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- Skin irritation, infection, and pneumothorax.
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- Fracture, breakage, migration, or loosening of the implant.
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- Inadequate or incomplete remodeling of the deformity or return of deformity, prior to or after removal of implant.
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- Permanent injury or death.
Substantial Equivalence
W. Lorenz considers the Lorenz Twist drills equivalent to the existing Twist drills which are classified as class I devices. W. Lorenz twist drills are also equivalent to Linvatec PowerPro Pneumatic System K032607 and Stryker Oral Max System K954690.
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing. The eagle faces right and is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Walter Lorenz Surgical, Inc. % Ms. Kim Reed Sr. Regulatory Specialist 1520 Tradeport Drive Jacksonville, Florida 32218
DEC - 4 2006
Re: K062842
Trade/Device Name: Lorenz Twist Drills Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBE Dated: November 17, 2006 Received: November 22, 2006
Dear Ms. Reed:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Kim Reed
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Saubare Mueller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K062842
Device Name: Lorenz Twist Drills
Indications For Use: The Lorenz Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
Prescription Use xx_______________________________________________________________________________________________________________________________________________________
Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buell
Page 1 of
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K06284
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).